AccessGUDID - DEVICE: GETINGE 46-SERIES (07340153700086)

GUDID

Device Identifier (DI) Information

Brand Name: GETINGE 46-SERIES
Version or Model: 46-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 46-5-503
Company Name: Getinge Disinfection AB

Primary DI Number: 07340153700086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354023236 *Terms of Use

Device Description: WASHER DISINFECTOR 46-5 D+W D, D+W D indicating double door machine with dryer. Cat no was 46-5-403. From March 2019 new cat no is 46-5-503.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35424	Surgical utensil washer/disinfector	A mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and disinfect (destroy microorganisms) reusable surgical instruments, bowls, anaesthesia equipment components, and some surgical footwear. Most instruments, especially those used invasively or in a sterile field will require sterilization after this process. It is typically located in rooms and central supply departments designed to handle soiled instruments/utensils. It typically includes internal baskets/racks in which the utensils are placed to ensure circulation of the heated water/detergents to all surfaces.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MEC	Disinfector, Medical Devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b2903f3d-b4d2-4bb1-816d-f54fc10200c6
Public Version Date: April 12, 2019
Public Version Number: 3
DI Record Publish Date: September 22, 2016